Early and Comprehensive Care Bundle in Elderly for Acute Heart Failure: a Stepped Wedge Cluster Randomized Trial (ELISABETH)

• ClinicalTrials.gov Identifier: NCT03683212
• Recruitment Status: Completed
• First Posted: September 25, 2018
• Last Update Posted: July 2, 2020
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Study Description

Brief Summary:

This is a prospective multicentre (N=15), stepped-wedge randomized trial that aims to evaluate the benefit of a protocolised comprehensive care bundle for early management of acute heart failure in the ED.

Condition or disease	Intervention/treatment	Phase
Acute Heart Failure	Procedure: Early intensive care bundle	Not Applicable

Detailed Description:

Acute heart failure (AHF) is one of the most common diagnoses for elderly patients in the emergency department (ED), with an admission rate higher than 80% and 1-month mortality around 10%. There is scarce evidence of any clinical added value of a specific treatment to improve outcomes, and European guidelines for the management of AHF are based on moderate levels of evidence, due to the lack of randomized controlled trials. Recent reports suggest that the very early administration of full recommended therapy may decrease mortality. However, several studies highlighted that elderly patients often received suboptimal treatment: For example, less than a third of them received nitrates therapy while it is recommended. Furthermore, a recent preliminary study reported that only 50% of them are assessed for precipitating factors - although it has been reported that precipitating factors are independently associated with mortality.

The hypothesis of the Elisabeth Study s is that an early care bundle that comprises early and comprehensive management of symptoms, along with prompt detection and treatment of precipitating factors should improve AHF outcome in elderly patients.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 503 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early and Comprehensive Care Bundle in Elderly for Acute Heart Failure: a Stepped Wedge Cluster Randomized Trial
• Actual Study Start Date: December 10, 2018
• Actual Primary Completion Date: November 12, 2019
• Actual Study Completion Date: November 12, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention period : early and comprehensive care bundle	Procedure: Early intensive care bundle; The care bundle comprises a list of items to follow and tick on a handover checklist within 4 hours of ED management: Treatment of the congestion: (international guidelines and recommendations); Treatment of precipitating factors; NIV (non-invasive ventilation) if respiratory distress with hypercapnia and pH < 7.35 in absence of contra indication.; Preventive LMWH (low molecular weight heparin) if no pre-existing anticoagulation therapy.
No Intervention: acute heart failure standard therapy

Outcome Measures

Primary Outcome Measures :

1. Number of days alive and out of hospital [ Time Frame: 30 days ]
   Number of days alive and out of hospital

Secondary Outcome Measures :

1. To evaluate the effect of AHF management on the 30-day cardiovascular death [ Time Frame: 30 days ]
   cardiovascular death
2. To evaluate the effect of AHF management on the 30-day all causes death [ Time Frame: 30 days ]
   all causes death
3. To evaluate the effect of AHF management on the hospital readmission at 30 days [ Time Frame: 30 days ]
   hospital readmission
4. To evaluate the effect of AHF management on the length of stay in hospital [ Time Frame: 30 days ]
   length of stay in hospital
5. To evaluate the effect of AHF management on changes of more than 2 fold in creatinine level from randomization to day 30 or to discharge whichever comes first [ Time Frame: 30 days ]
   creatinine level

Eligibility Criteria

• Ages Eligible for Study: 75 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients aged 75 years and older admitted to the emergency department with a diagnosis of acute heart failure determined by the emergency physician, based on the presence of:

  • at least one of the following symptoms : acute, or worsening of dyspnea, orthopnea
  • one or more of the followings: pulmonary rales, peripheral edema, a chest radiograph or transthoracic echocardiography showing pulmonary vascular congestion signs, increased natriuretic peptides (BNP or NT-pro-BNP).
  • Patients affiliated to French social security ("AME excepted")
  • Written informed consent signed by the patient / the trustworthy person / family member / close relative, or inclusion in case of emergency and written informed consent will been signed by the patient (if need be by trustworthy person, family member or close relative) as soon as possible (article L1122-1-2 of the French Public Health Code)

Exclusion Criteria:

• Patients are excluded if they have any of the followings:

  • other obvious cause of acute illness (severe sepsis, ST elevation Myocardial infarction)
  • systolic blood pressure less than 100 mmHg
  • severe mitral or aortic stenosis, or severe aortic regurgitation
  • known chronic kidney injury on dialysis
  • shock from any cause
  • Time from ED entrance to inclusion > 6h
• Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom

Contacts and Locations

Locations

France

Emergency department Hospital Pitié-Salpêtrière

Paris, France, 75013

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Yonathan Freund, Doctor; Assistance Publique - Hôpitaux de Paris

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Freund Y, Cachanado M, Delannoy Q, Laribi S, Yordanov Y, Gorlicki J, Chouihed T, Féral-Pierssens AL, Truchot J, Desmettre T, Occelli C, Bobbia X, Khellaf M, Ganansia O, Bokobza J, Balen F, Beaune S, Bloom B, Simon T, Mebazaa A. Effect of an Emergency Department Care Bundle on 30-Day Hospital Discharge and Survival Among Elderly Patients With Acute Heart Failure: The ELISABETH Randomized Clinical Trial. JAMA. 2020 Nov 17;324(19):1948-1956. doi: 10.1001/jama.2020.19378.

Freund Y, Gorlicki J, Cachanado M, Salhi S, Lemaître V, Simon T, Mebazaa A. Early and comprehensive care bundle in the elderly for acute heart failure in the emergency department: study protocol of the ELISABETH stepped-wedge cluster randomized trial. Trials. 2019 Jan 31;20(1):95. doi: 10.1186/s13063-019-3188-8.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT03683212
• Other Study ID Numbers: K170918J; 2018-A01139-46 ( Other Identifier: ANSM )
• First Posted: September 25, 2018
• Last Update Posted: July 2, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Emergency department; Elderly; Acute heart failure; Pulmonary edema

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases